Clinical trial · Interventional
Anakinra in Treating Patients With Metastatic Cancer Expressing the Interleukin-1 Gene
Phase I Study of Anakinra Mediated Tumor Regression and Angiogenesis Inhibition in Subjects With Cancers Producing Interleukin-1
NCT00072111CI-TRIAL-00017735completedPhase 1ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
RATIONALE: Biological therapies, such as anakinra, may interfere with the growth of the tumor cells and slow the growth of metastatic tumors that express the interleukin-1 gene. PURPOSE: This phase I trial is studying the side effects and best dose of anakinra in treating patients with metastatic cancer that expresses the interleukin-1 gene.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Unspecified Adult Solid Tumor, Protocol Specific | Adult Solid Neoplasm | ALIAS | 0.85 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| anakinra | Biological | — | UNRESOLVED |
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
DISEASE CHARACTERISTICS: * Diagnosis of metastatic cancer * Measurable disease * Able to be percutaneously biopsied with minimum morbidity on protocol NCI-99-C-0128 * Tumor expression of interleukin-1 by biopsy * Progressive disease during prior standard first-line chemotherapy OR refused standard first-line chemotherapy * No active intracranial or leptomeningeal metastases * Prior radiotherapy to or resection of intracranial metastatic disease allowed provided there is no evidence of active disease on MRI or CT scan for the past month AND there is no requirement for concurrent anticonvulsant or steroid medications PATIENT CHARACTERISTICS: Age * 18 and over Performance status * ECOG 0-2 Life expectancy * At least 4 months Hematopoietic * Platelet count greater than 75,000/mm\^3 * Absolute neutrophil count greater than 1,500/mm\^3 Hepatic * PT within 2 seconds of the upper limit of normal * Bilirubin less than 1.5 mg/dL Renal * Creatinine no greater than 1.6 mg/dL OR * Creatinine clearance greater than 30 mL/min Other * Not pregnant or nursing * Negative pregnancy test * No allergy to proteins made from bacteria * No active infection * HIV negative PRIOR CONCURRENT THERAPY: Biologic therapy * More than 30 days since prior biologic therapy * No concurrent systemic immune modulators Chemotherapy * See Disease Characteristics * More than 30 days since prior chemotherapy Endocrine therapy * See Disease Characteristics * No concurrent steroids Radiotherapy * See Disease Characteristics * More than 14 days since prior localized radiotherapy to non-target lesions and recovered * More than 30 days since other prior radiotherapy Surgery * See Disease Characteristics Other * At least 30 days since prior antibiotic therapy for infection
References
Publications (0)
Data not yet available
No reference posted for this study.